Ponsky-Gauderer Silicone PEG Tray 000329Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741080906), received between Feb 13, 2020 and Dec 3, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2020Migration; Migration

  IT WAS REPORTED POST A TUBE INSERTION PROCEDURE, THE TUBE ALLEGEDLY MIGRATED INTO THE PATIENT'S ABDOMINAL WALL AND REQUIRED ADDITIONAL INTERVENTION. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10939938 ↗
• InjuryFeb 13, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE REMOVAL, THE TUBE ALLEGEDLY BROKE AND A FRAGMENT REMAINS IN THE PATIENT¿S ABDOMEN. PATIENT STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9709003 ↗
• InjuryFeb 13, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE REMOVAL, THE TUBE ALLEGEDLY BROKE AND A FRAGMENT REMAINS IN THE PATIENT¿S ABDOMEN. PATIENT STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9708890 ↗